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Assessment of CR8020, a Monoclonal Antibody Against Influenza A Viruses

NCT01756950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-12-19

No results posted yet for this study

Summary

The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal antibody against influenza A viruses.

Conditions

Interventions

BIOLOGICAL

2 mg/kg CR8020

administered as a single 2-hour intravenous infusion

BIOLOGICAL

5 mg/kg CR8020

administered as a single 2-hour intravenous infusion

BIOLOGICAL

15 mg/kg CR8020

administered as a single 2-hour intravenous infusion

BIOLOGICAL

30 mg/kg CR8020

administered as a single 2-hour intravenous infusion

BIOLOGICAL

50 mg/kg CR8020

administered as a single 2-hour intravenous infusion

BIOLOGICAL

Placebo

administered as a single 2-hour intravenous infusion

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • David R Mathews, MD · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01756950 on ClinicalTrials.gov